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Lonza to develop a GMP-compliant process for Exo-101 manufacturing from its Siena (IT) site
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Exo-101 has shown safety and efficacy in multiple pre-clinical trials, and is expected to reach patients in 2027
Basel, Switzerland and Cantanhede, Portugal, 11 March 2025 – Exogenus Therapeutics, a Portuguese biotech company, and Lonza, a global development and manufacturing partner to the pharmaceutical and biotech markets, announced today a collaboration to develop Exo-101, Exogenus’ exosome-based lead candidate.
Exogenus Therapeutics specializes in the development of healthcare solutions based on extracellular vesicles, including exosomes and other nanotechnologies. The company’s lead product, Exo-101, derived from immunologically privileged cells from umbilical cord blood, has been shown to have regenerative, anti‑inflammatory and immunomodulatory properties in multiple preclinical models and is expected to reach patients in 2027. Its multifactorial mode-of-action, mediated by a cocktail of small RNAs, proteins and anti-inflammatory lipids, provides the foundation for the drug’s therapeutic potential and positive safety profile.1,2 Exo-101 targets patients lacking effective treatment options primarily in the areas of tissue regeneration and inflammatory diseases.
Under the agreement, Lonza will leverage its expertise in exosome development and analytical services from its Siena (IT) site and dedicate a team of experts to define a GMP-compliant process for Exo-101 production, based on the foundational work of Exogenus Therapeutics.3 This feasibility effort aims to define the path towards Exo-101 manufacturing for clinical supply.
Joana Correia, Co-Founder and CEO, Exogenus Therapeutics, commented: “We are committed to developing innovative, safe and effective therapies in areas of high unmet medical needs, and to establishing new uses for biological waste materials. This collaboration with Lonza will be essential to achieve a robust, GMP-compliant process for Exo-101 manufacturing, as we progress towards clinical studies. We are excited to partner with a like-minded team with shared goals for the future of exosome‑based technologies.”
Davide Zocco, Head of Exosomes Development, Lonza, added: “At Lonza, we continue to pioneer this emerging and promising field of exosomes, leading innovation to provide development and manufacturing services for our partners. This collaboration highlights our market-leading expertise in supporting exosomes and other extracellular vesicle-based products. We look forward to collaborating with Exogenus Therapeutics to advance its lead candidate towards the clinic.”
[1] Rodrigues et al, Int. J. Mol. Sci. 2021, 22(18), 9797
[2] Rodrigues et al, Membranes 2021, 11(9), 647
[3] Cardoso et al, STEM CELLS Transl Med. 2021, 10, 910
Additional Information
For additional information about Exogenus Therapeutics, visit www.exogenus-t.com.
For more information about Lonza’s exosomes offering, visit Lonza | Exosomes.